Lead Insertion Tool With Self-Biasing Engagement Mechanism
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Solution Overview
Problem
Implantable leads used in medical devices like pacemakers and cardioverter defibrillators face challenges with column strength, making them difficult to re-insert during revision surgeries, leading to potential damage and increased surgical risks.
Innovation Solution
A lead insertion tool with a clamshell structure and engagement mechanism that provides column strength and guides the lead connector end into the IPG header receptacle, minimizing the risk of damage through controlled compression and incremental insertion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If the lead is made more flexible to reduce lead fracture, then lead flexibility is improved, but column strength deteriorates
Solution Approach 1:
The insertion tool acts as an intermediary device that temporarily provides column strength to the flexible lead during the insertion process. The tool's lumen receives and supports the lead, while engagement mechanisms grip the lead to prevent displacement, allowing the flexible lead to be inserted without buckling or damage.
2Ease of operation
If the physician pinches the lead to advance it during revision surgery, then insertion control is improved, but lead damage risk increases
Solution Approach 1:
The insertion tool replaces the physician's direct pinching action with a specialized intermediary device. The engagement mechanisms within the tool's lumen provide controlled gripping and advancement of the lead, eliminating the need for direct manual pinching and reducing the risk of lead damage.
Solution Approach 2:
The engagement mechanisms are self-biasing, automatically engaging with the lead when the tool is properly positioned and maintaining control without requiring continuous manual adjustment. This self-service mechanism reduces operator effort and minimizes the risk of accidental lead damage.
3Manufacturing precision
If the lead is advanced by small incremental shifts, then insertion precision is improved, but surgical time increases
Solution Approach 1:
The lead is pre-loaded into the insertion tool's lumen before the insertion procedure begins. This preliminary action allows the lead to be positioned and secured in advance, enabling faster and more precise insertion when the tool is advanced into the IPG header without requiring multiple incremental adjustments during surgery.
Data Source
AI summary
Disclosed herein is a lead insertion tool for inserting a lead connector end of an implantable lead into a lead receptacle of a header of an implantable pulse generator, the implantable lead including a lead body extending distally from the lead connector end. The tool includes a lead pathway and an engagement mechanism. The lead pathway extends through the tool and is configured to receive the implantable lead. The engagement mechanism includes an engaged state and a self-biasing non-engaged state. When the engagement mechanism is self-biased into the non-engaged state, the implantable lead is free to displace along the lead pathway. When the engagement mechanism is forced into the engaged state, the lead cannot displace along the lead pathway.